Generic Name: prothrombin complex concentrate (human) (pro-THROM-bin)
Brand Name: Kcentra
Patients are treated with vitamin K antagonists (eg, warfarin) because they have health problems that put them at increased risk for blood clots. Very bad and sometimes deadly blood clots have occurred after using Kcentra to reverse the effects of vitamin K antagonists. Talk with your doctor about using Kcentra to reverse the effects of the vitamin K antagonist, especially if you have ever had a blood clot. Tell your doctor if you have had a blood clot, heart attack, a certain blood problem (disseminated intravascular coagulation [DIC]), stroke or transient ischemic attack (TIA), chest pain, or severe blood vessel disease within the past 3 months. You need to be sure that the benefits of using Kcentra outweigh the risks.
Kcentra is used for:
Reversing the effects of a vitamin K antagonist (eg, warfarin) in people with major bleeding or who need to have surgery or another procedure right away. It may also be used for other conditions as determined by your doctor.
Kcentra is a human clotting factor complex derived from human plasma. It works by increasing the amount of certain clotting factors in the blood, which helps the blood form clots and stop bleeding.
Do NOT use Kcentra if:
- you are allergic to any ingredient in Kcentra, heparin, or to other products that are made from human plasma
- you have DIC
- you have a history of low platelet counts after taking heparin
Contact your doctor or health care provider right away if any of these apply to you.
Before using Kcentra:
Some medical conditions may interact with Kcentra. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of blood clots, blood or bleeding problems (eg, DIC), heart attack, blood vessel problems, stroke or TIA (mini-stroke), or chest pain
Some MEDICINES MAY INTERACT with Kcentra. However, no specific interactions with Kcentra are known at this time.
Ask your health care provider if Kcentra may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Kcentra:
Use Kcentra as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Kcentra is given as an injection at your doctor's office, hospital, or clinic.
- Only 1 dose of Kcentra is required. If you miss a dose of Kcentra, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Kcentra.
Important safety information:
- Kcentra comes from human blood. Rarely, patients receiving products that come from human blood have developed certain viral infections (eg, hepatitis A) or a central nervous system disease called Creutzfeldt-Jakob disease. No cases of these problems have been found in patients who have used Kcentra. Discuss any questions or concerns with your doctor.
- Kcentra should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Kcentra can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Kcentra while you are pregnant. It is not known if Kcentra is found in breast milk. If you are or will be breast-feeding while you use Kcentra, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Kcentra:
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Headache; joint pain; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty or fast breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); calf or leg pain, swelling, redness, or tenderness; chest, jaw, or arm pain or pressure; confusion; coughing up blood; fainting; fast heartbeat; one-sided weakness; severe or persistent dizziness or headache; shortness of breath; slurred speech; stomach pain or swelling; trouble walking or moving around; unusual or persistent bruising or bleeding; vision problems.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Kcentra:
Kcentra is usually handled and stored by a health care provider. If you are using Kcentra at home, store Kcentra as directed by your pharmacist or health care provider. Keep Kcentra out of the reach of children and away from pets.
- If you have any questions about Kcentra, please talk with your doctor, pharmacist, or other health care provider.
- Kcentra is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Kcentra or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Kcentra. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Kcentra. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Kcentra.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.